In a vote held today in Strasbourg, France, 621 members of the European Parliament approved the draft regulation, with only 10 voting against and 22 abstentions. The document, which updates 1995 rules, is based on a 2012 proposal by the European Commission.

Many research organizations are worried about changes made last fall by Parliament's civil liberties committee that define conditions under which researchers can use (or reuse) patients' data without specific consent. One key change allows the obligation to get consent to be lifted only if the research serves a “high public interest … [and] cannot possibly be carried out otherwise.” Supporters say that the changes are reasonable and necessary to ensure privacy, but scientists argue that the new language is too strict, vague, and threatens important health research.

“We are very disappointed that the damaging amendments relating to research have made it into Parliament's position on the regulation,” Beth Thompson, a policy adviser at the United Kingdom's Wellcome Trust, tells ScienceInsider in an e-mail.

The reform is not sealed, as the Parliament must now negotiate with the Council of Ministers, which represents the bloc's 28 member states. “We hope that we can still change things, for the good of biomedical research and for the benefit of patients,” says Nathalie Kayadjanian, senior scientific officer for the medical scientific committee of Science Europe, a group of science funders and research organizations.

Medical research is only a small part of the larger debate over privacy, and the U.S. spying scandals uncovered last year have prompted citizens and politicians to take a tough stance. “We must bear in mind that in Europe the notion of personal data protection is not a passing trend or a fleeting cause, it is a longstanding fundamental right,” said Monique Goyens, director general of the European Consumer Organisation, BEUC, in a statement after the vote.